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March 1993, Vol 147, No. 3 >
Article | March 1993

Comparison of the Safety and Immunogenicity of Acellular (BIKEN) and Whole-Cell Pertussis Vaccines in 15- to 20-Month-Old Children FREE

John F. Marcinak, MD; Mark Ward, MD; Arthur L. Frank, MD; Kenneth M. Boyer, MD; James E. Froeschle, MD; Philip H. Hosbach
[+] Author Affiliations

Accepted for publication September 14, 1992.

Reprint requests to Department of Pediatrics (M/C 856), The University of Illinois at Chicago, 840 S Wood St, Chicago, IL 60612 (Dr Marcinak).


Am J Dis Child. 1993;147(3):290-294. doi:10.1001/archpedi.1993.02160270052017.
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• Objective.  —To compare the immunogenicity and reactogenicity of a two-component acellular pertussis vaccine (BIKEN) with whole-cell diphtheria and tetanus toxoids and pertussis vaccine (WC-DTP) when administered to children aged 15 to 20 months.

Design.  —A randomized, double-blind study.

Setting.  —Children in this study were from 12 general pediatric practices (11 were private and one was university-affiliated) and one inner-city university pediatric clinic.

Participants.  —Two hundred forty-six children aged 15 to 20 months who had received a three-dose primary series of standard WC-DTP vaccine during infancy.

Selection Procedures.  —Children were randomly assigned to receive either WC-DTP or one of three lots of acellular diphtheria and tetanus toxoids and pertussis vaccine (DT-aP) in a 1:3 ratio at the 11 private practices and in a 1:1 ratio at the university-affiliated practice and inner-city university pediatric clinic.

Interventions.  —The DT-aP vaccines contained 23.4 μg each of pertussis toxin and filamentous hemagglutinin per 0.5 mL and the same concentrations of diphtheria and tetanus toxoids as WC-DTP. Serum samples were obtained on the day of immunization and 4 to 6 weeks later. Adverse reactions at 6, 24, 48, and 72 hours were recorded by parents who were contacted by telephone at 24 and 72 hours and 14 days after immunization.

Measurements/Main Results.  —An indirect enzyme-linked immunosorbent assay method was used to determine IgG antibody response to pertussis toxin and filamentous hemagglutinin and IgG, IgA, and IgM to tetanus toxoids; a Chinese hamster ovary cell assay was used to measure functional antibodies to pertussis toxin; serum neutralization on VERO cells assayed diphtheria antitoxin. Recipients of the DT-aP vaccine had fewer local reactions in the first 6 to 48 hours and fewer systemic reactions at 24 hours than did recipients of the WC-DTP vaccine. Acetaminophen was administered to 31% of DT-aP recipients compared with 63% of WC-DTP recipients. Infants given DT-aP had higher geometric mean antibody titer levels against pertussis antigens after vaccination.

Conclusions.  —The BIKEN DT-aP vaccine used in this study is less reactogenic and more immunogenic for selected pertussis antigens than the WC-DTP vaccine in children aged 15 to 20 months.(AJDC. 1993;147:290-294)

REFERENCES

1 +
Ayoma T, Hagiwara S, Murase Y, Kato T, Iwata T.  Adverse reactions and antibody responses to acellular pertussis vaccine . J Pediatr. 1986;;109:925-930.
2 +
American Academy of Pediatrics Committee on Infectious Disease.  Acellular pertussis vaccines: recommendations for use as the fourth and fifth doses . Pediatrics . 1992;;90:121-123.
3 +
Centers for Disease Control.  FDA approval of use of diphtheria and tetanus toxoids and acellular pertussis vaccine . MMWR . 1991;;40:881-882.
4 +
Ad Hoc Group for the Study of Pertussis Vaccines.  Placebo-controlled trial of two acellular pertussis vaccines in Sweden: protective efficacy and adverse events . Lancet . 1988;;1:955-960.
5 +
Blennow M, Granstrom M.  Adverse reactions and serologic response to a booster dose of acellular pertussis vaccine in children immunized with acellular or whole-cell vaccine as infants . Pediatrics . 1989;;84:62-67.
6 +
Gillenius P, Jaatmaa E, Askelof P, Granstrom M, Tiru M.  The standardization of an assay for pertussis toxin and antitoxin in microplate culture of Chinese hamster ovary cells . J Biol Standardization . 1985;;13:61-66.
7 +
Manclark LR, Meade BD, Burstyn DG.  Serological response to Bordetella pertussis . In: Rose NR, Friedman H, Fahey JL, eds. Manual of Clinical Laboratory Immunology . 3rd ed. Washington, DC: American Society for Microbiology; 1986;:388-394.
8 +
Craig J P.  Immune response to Corynebacterium diphtheria and Clostridium tetani . In: Rose NR, Friedman H, Fahey JL, eds. Manual of Clinical Laboratory Immunology . 3rd ed. Washington, DC: American Society for Microbiology; 1986;:408-414.
9 +
Lewis K, Cherry JD, Holroyd J, Baker LR, Dudenhoeffer FE, Robinson RG.  A double-blind study comparing an acellular pertussis-component DTP vaccine with whole-cell pertussis-component DTP vaccine in 18-month-old children . AJDC . 1986;;140:872-876.
10 +
Pichichero ME, Budgett JT, Rodgers GC, McLinn S, Trevino-Scatterday B, Nelson JD.  Acellular pertussis vaccine: immunogenicity and safety of an acellular pertussis vs a whole cell pertussis vaccine combined with diphtheria and tetanus toxoids as a booster in 18-to 24-month-old children . Pediatr Infect Dis J. 1987;;6:352-363.
11 +
Edwards KM, Lawrence E, Wright PF.  Diphtheria, tetanus, and pertussis vaccine: a comparison of the immune response and adverse reactions to conventional and acellular pertussis components . AJDC . 1986;;140:867-871.
12 +
Anderson EL, Belshe RB, Bartram J, et al.  Clinical and serologic responses to acellular pertussis vaccine in infants and young children . AJDC . 1987;;141:949-953.
13 +
Blumberg DA, Mink CM, Cherry JD, et al.  Comparison of an acellular pertussis-component diphtheria-tetanus-pertussis (DTP) vaccine with a whole-cell pertussis-component DTP vaccine in 17- to 24-month-old children, with measurement of 69-kilodalton outer membrane protein antibody . J Pediatr. 1990;;117:46-51.
14 +
Tomoda T, Ogura H, Kurashige T.  Immune responses to Bordetella pertussis infection and vaccination . J Infect Dis. 1991;;163:559-563.
15 +
Edwards KM, Bradley RB, Decker MD, et al.  Evaluation of a new highly purified pertussis vaccine in infants and children . J Infect Dis. 1989;;160: 832-837.
16 +
Noble GR, Bernier RH, Esber EC, et al.  Acellular and whole-cell pertussis vaccines in Japan: report of a visit by US scientists . JAMA . 1987;;257: 1351-1356.
17 +
Feldman S, Perry S, Andrew M, et al.  Comparison of acellular (B-type) and whole-cell pertussis-component diphtheria-tetanus-pertussis vaccines as the first booster immunization in 15- to 24-month-old children . J Pediatr. 1992;;121:857-861.
18 +
Kovel A, Wald ER, Guerra N, Serdy C, Meschievitz CK.  Safety and immunogenicity of acellular diphtheria-tetanus-pertussis and Haemophilus conjugate vaccines given in combination or at separate injection sites . J Pediatr. 1992;;120:84-87.
19 +
Edwards KM, Decker MD, Bradley RB, Taylor JC, Hager CC.  Booster response to acellular pertussis vaccine in children primed with acellular or whole cell vaccines . Pediatr Infect Dis J. 1991;;10:315-318.
20 +
Bernstein HH, Rothstein EP, Pichichero ME, et al.  Clinical reactions and immunogenicity of the BIKEN acellular diphtheria and tetanus toxoids and pertussis vaccine in 4- through 6-year-old US children . AJDC . 1992;; 146:556-559.
21 +
Edwards KM, Decker MD, Halsey NA, et al.  Differences in antibody response to whole-cell pertussis vaccines . Pediatrics . 1991;;88:1019-1023.
22 +
Storsaeter J, Blackwelder WC, Hallander HO.  Pertussis antibodies, protection, and vaccine efficacy after household exposure . AJDC . 1992;;146: 167-172.
23 +
Aoyama T, Murase Y, Gonda T, Iwata T.  Type-specific efficacy of acellular pertussis vaccine . AJDC . 1988;;142:40-42.
24 +
Aoyama T, Murase Y, Kato M, Iwai H, Iwata T.  Efficacy and immunogenicity of acellular pertussis vaccine by manufacturer and patient age . AJDC . 1989;;143:655-659.

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References

1 +
Ayoma T, Hagiwara S, Murase Y, Kato T, Iwata T.  Adverse reactions and antibody responses to acellular pertussis vaccine . J Pediatr. 1986;;109:925-930.
2 +
American Academy of Pediatrics Committee on Infectious Disease.  Acellular pertussis vaccines: recommendations for use as the fourth and fifth doses . Pediatrics . 1992;;90:121-123.
3 +
Centers for Disease Control.  FDA approval of use of diphtheria and tetanus toxoids and acellular pertussis vaccine . MMWR . 1991;;40:881-882.
4 +
Ad Hoc Group for the Study of Pertussis Vaccines.  Placebo-controlled trial of two acellular pertussis vaccines in Sweden: protective efficacy and adverse events . Lancet . 1988;;1:955-960.
5 +
Blennow M, Granstrom M.  Adverse reactions and serologic response to a booster dose of acellular pertussis vaccine in children immunized with acellular or whole-cell vaccine as infants . Pediatrics . 1989;;84:62-67.
6 +
Gillenius P, Jaatmaa E, Askelof P, Granstrom M, Tiru M.  The standardization of an assay for pertussis toxin and antitoxin in microplate culture of Chinese hamster ovary cells . J Biol Standardization . 1985;;13:61-66.
7 +
Manclark LR, Meade BD, Burstyn DG.  Serological response to Bordetella pertussis . In: Rose NR, Friedman H, Fahey JL, eds. Manual of Clinical Laboratory Immunology . 3rd ed. Washington, DC: American Society for Microbiology; 1986;:388-394.
8 +
Craig J P.  Immune response to Corynebacterium diphtheria and Clostridium tetani . In: Rose NR, Friedman H, Fahey JL, eds. Manual of Clinical Laboratory Immunology . 3rd ed. Washington, DC: American Society for Microbiology; 1986;:408-414.
9 +
Lewis K, Cherry JD, Holroyd J, Baker LR, Dudenhoeffer FE, Robinson RG.  A double-blind study comparing an acellular pertussis-component DTP vaccine with whole-cell pertussis-component DTP vaccine in 18-month-old children . AJDC . 1986;;140:872-876.
10 +
Pichichero ME, Budgett JT, Rodgers GC, McLinn S, Trevino-Scatterday B, Nelson JD.  Acellular pertussis vaccine: immunogenicity and safety of an acellular pertussis vs a whole cell pertussis vaccine combined with diphtheria and tetanus toxoids as a booster in 18-to 24-month-old children . Pediatr Infect Dis J. 1987;;6:352-363.
11 +
Edwards KM, Lawrence E, Wright PF.  Diphtheria, tetanus, and pertussis vaccine: a comparison of the immune response and adverse reactions to conventional and acellular pertussis components . AJDC . 1986;;140:867-871.
12 +
Anderson EL, Belshe RB, Bartram J, et al.  Clinical and serologic responses to acellular pertussis vaccine in infants and young children . AJDC . 1987;;141:949-953.
13 +
Blumberg DA, Mink CM, Cherry JD, et al.  Comparison of an acellular pertussis-component diphtheria-tetanus-pertussis (DTP) vaccine with a whole-cell pertussis-component DTP vaccine in 17- to 24-month-old children, with measurement of 69-kilodalton outer membrane protein antibody . J Pediatr. 1990;;117:46-51.
14 +
Tomoda T, Ogura H, Kurashige T.  Immune responses to Bordetella pertussis infection and vaccination . J Infect Dis. 1991;;163:559-563.
15 +
Edwards KM, Bradley RB, Decker MD, et al.  Evaluation of a new highly purified pertussis vaccine in infants and children . J Infect Dis. 1989;;160: 832-837.
16 +
Noble GR, Bernier RH, Esber EC, et al.  Acellular and whole-cell pertussis vaccines in Japan: report of a visit by US scientists . JAMA . 1987;;257: 1351-1356.
17 +
Feldman S, Perry S, Andrew M, et al.  Comparison of acellular (B-type) and whole-cell pertussis-component diphtheria-tetanus-pertussis vaccines as the first booster immunization in 15- to 24-month-old children . J Pediatr. 1992;;121:857-861.
18 +
Kovel A, Wald ER, Guerra N, Serdy C, Meschievitz CK.  Safety and immunogenicity of acellular diphtheria-tetanus-pertussis and Haemophilus conjugate vaccines given in combination or at separate injection sites . J Pediatr. 1992;;120:84-87.
19 +
Edwards KM, Decker MD, Bradley RB, Taylor JC, Hager CC.  Booster response to acellular pertussis vaccine in children primed with acellular or whole cell vaccines . Pediatr Infect Dis J. 1991;;10:315-318.
20 +
Bernstein HH, Rothstein EP, Pichichero ME, et al.  Clinical reactions and immunogenicity of the BIKEN acellular diphtheria and tetanus toxoids and pertussis vaccine in 4- through 6-year-old US children . AJDC . 1992;; 146:556-559.
21 +
Edwards KM, Decker MD, Halsey NA, et al.  Differences in antibody response to whole-cell pertussis vaccines . Pediatrics . 1991;;88:1019-1023.
22 +
Storsaeter J, Blackwelder WC, Hallander HO.  Pertussis antibodies, protection, and vaccine efficacy after household exposure . AJDC . 1992;;146: 167-172.
23 +
Aoyama T, Murase Y, Gonda T, Iwata T.  Type-specific efficacy of acellular pertussis vaccine . AJDC . 1988;;142:40-42.
24 +
Aoyama T, Murase Y, Kato M, Iwai H, Iwata T.  Efficacy and immunogenicity of acellular pertussis vaccine by manufacturer and patient age . AJDC . 1989;;143:655-659.

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